Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-06 @ 10:41 PM
Study NCT ID:
NCT03663556
Status:
UNKNOWN
Last Update Posted:
2018-10-02
First Post:
2018-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Meconium and stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-28', 'studyFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline intestinal microbiota composition of preterm infants at 7, 14 and 21 days.', 'timeFrame': 'The first fecal sample (meconium) of preterm infants will be collected. Afterwards, fecal samples will be collected every 7 days, during 21 days.', 'description': 'The intestinal microbiota profile of preterm infants will be evaluated over time.'}, {'measure': 'Changes from baseline intestinal microbiota composition of preterm infants in relation to infant-feeding profile (breast milk, donor human milk or formula) at 7,14 and 21 days.', 'timeFrame': 'Infant-feeding type of preterm infants before the first, second, third and fourth collection will be recorded during these 21 days.', 'description': 'Infant-feeding profile (breast milk, donor human milk or formula) will be recorded every day to select the most representative type of infant-feeding (\\> 50 %) received during the 7 days prior to each fecal sample collection.'}], 'secondaryOutcomes': [{'measure': 'Maternal intestinal microbiota composition, analyzed by RT-PCR.', 'timeFrame': 'Maternal fecal samples will be collected after delivery up to 1 week.', 'description': "Mother's will be asked to collect their own fecal samples for gut microbiota analysis by RT-PCR. An appropriate stool collection kit will be provided (EasySampler Stool Collection kit)."}, {'measure': 'Changes in maternal gut microbiota in relation to clinical variables described below', 'timeFrame': 'Clinical variables will be collected daily, until study completion an average of 2 years.', 'description': "Changes in intestinal microbiota profile of preterm infants' mothers will be evaluated in relation to mode of delivery, mother's gestational age, dietary pattern during pregnancy, weight gain in gestation and antibiotic exposure."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intestinal microbiota', 'preterm infants', 'breast milk', 'donor human milk', 'formula'], 'conditions': ['Very Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '32658601', 'type': 'DERIVED', 'citation': 'Morais J, Marques C, Teixeira D, Durao C, Faria A, Brito S, Cardoso M, Macedo I, Pereira E, Tome T, Calhau C. Extremely preterm neonates have more Lactobacillus in meconium than very preterm neonates - the in utero microbial colonization hypothesis. Gut Microbes. 2020 Nov 9;12(1):1785804. doi: 10.1080/19490976.2020.1785804. Epub 2020 Jul 13.'}]}, 'descriptionModule': {'briefSummary': "Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse. Several factors may influence infants' microbiota such as mother's diet, mode of delivery, antibiotic exposure and type of feeding. The main goal of this observational study is to evaluate the impact of different types of feeding (breast milk, donor human milk and preterm formulas) on the intestinal microbiota of preterm infants hospitalized in the neonatal intensive care unit (NICU) of Maternidade Alfredo da Costa (MAC). Furthermore, the influence of mode of delivery and the mother's diet, among others factors, on vertical microbiota transmission will be evaluated. After delivery, mothers will be asked to collect their own fecal samples and will be invited to complete a semi-quantitative food frequency questionnaire. Stool samples will be collected from premature infants every 7 days. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.", 'detailedDescription': "Meconium and the additional 3 fecal samples will be collected from preterm infants by the nursing team of MAC Neonatology Unit. Fecal samples will be collected every 7 days, during 21 days, from diapers into sterile tubes. Mothers will be asked to collect their own fecal samples with an appropriate stool collection kit (EasySampler®) and will be invited to complete a semi-quantitative food frequency questionnaire, previously validated for the Portuguese population.\n\nInfant-feeding profile (breast milk, donor human milk or formula) of preterm infants will be recorded every day to select the most representative (\\>50 %) type of infant-feeding received during the 7 days prior to each fecal sample collection.\n\nAdditionally, detailed clinical data will be collected during the preterm infant enrollment in the study. Personal clinical data includes sociodemographic information and clinical intrapartum and postpartum outcomes, such as newborn's weight, days of antibiotic exposure, number of total days of hospitalization and others outcomes related to the preterm clinical evolution."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Very preterm infants born with less than 32 weeks recruited at the NICU of Maternidade Dr. Alfredo da Costa, Centro Hospitalar de Lisboa Central, Lisbon, Portugal', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be eligible for enrolment, preterm infants must have been admitted to the NICU in less than 24 hours of life, have been born with less than 32 weeks with absence of malformations or metabolic diseases.\n\nExclusion Criteria:\n\n* non applicable'}, 'identificationModule': {'nctId': 'NCT03663556', 'acronym': 'FEEDMI', 'briefTitle': 'Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development', 'orgStudyIdInfo': {'id': 'FEEDMI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Very Preterm Infants', 'description': 'Newborn infants with less than 32 weeks admitted in the NICU.', 'interventionNames': ['Other: Infant-feeding']}], 'interventions': [{'name': 'Infant-feeding', 'type': 'OTHER', 'description': 'Preterm infants hospitalized in the NICU can be feed by three different types of infant feeding, such as breast milk, donor human milk and/or formulas.', 'armGroupLabels': ['Very Preterm Infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050-010', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Sara Brito, MD', 'role': 'CONTACT', 'email': 'sarabri@gmail.com;', 'phone': '+351 964 278 547'}, {'name': 'Juliana Morais, BsC', 'role': 'CONTACT', 'email': 'ju_morais17@hotmail.com', 'phone': '+351 362711106'}, {'name': 'Sara Brito, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manuela Cardoso, BsC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teresa Tomé, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Israel Macedo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maternidade Dr. Alfredo da Costa, Centro Hospitalar de Lisboa Central', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1169-056', 'city': 'Lisbon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Portugal', 'facility': 'NOVA Medical School, Universidade Nova de Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'centralContacts': [{'name': 'Sara Brito, MD', 'role': 'CONTACT', 'email': 'sarabri@gmail.com', 'phone': '+351 964278547'}, {'name': 'Conceição Calhau, PhD', 'role': 'CONTACT', 'email': 'ccalhau@nms.unl.pt', 'phone': '+351 218 803 000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Health Technology and Services Research', 'class': 'OTHER'}, {'name': 'Maternidade Dr. Alfredo da Costa', 'class': 'UNKNOWN'}, {'name': 'Universidade Nova de Lisboa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}